search
Back to results

Vascular Effects of Hesperidin in Metabolic Syndrome

Primary Purpose

Endothelial Dysfunction, Metabolic Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Hesperidin
Placebo
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Dysfunction focused on measuring endothelial, metabolic syndrome, hesperidin

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Metabolic Syndrome (ATPIII criteria)
  • BMI <35
  • Age 20-55

Exclusion Criteria:

  • History of cancer.
  • History of cardiovascular diseases.
  • Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.

Sites / Locations

  • University of Rome Tor VergataRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hesperidin, 500 mg per day

Placebo

Arm Description

500 mg daily of oral Hesperidin for 3 weeks

Outcomes

Primary Outcome Measures

Safety of oral supplementation of hesperidin

Secondary Outcome Measures

Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.

Full Information

First Posted
June 3, 2009
Last Updated
June 16, 2009
Sponsor
University of Rome Tor Vergata
search

1. Study Identification

Unique Protocol Identification Number
NCT00914251
Brief Title
Vascular Effects of Hesperidin in Metabolic Syndrome
Official Title
Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rome Tor Vergata

4. Oversight

5. Study Description

Brief Summary
It has been suggested that cardiovascular risk factors either independently or in cluster (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be explored, no data on in vivo vascular effect of this flavanone has been ever acquired.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Metabolic Syndrome
Keywords
endothelial, metabolic syndrome, hesperidin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hesperidin, 500 mg per day
Arm Type
Active Comparator
Arm Description
500 mg daily of oral Hesperidin for 3 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hesperidin
Intervention Description
Administration of oral Hesperidin, 500 mg/daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of oral Placebo, 500 mg/daily
Primary Outcome Measure Information:
Title
Safety of oral supplementation of hesperidin
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metabolic Syndrome (ATPIII criteria) BMI <35 Age 20-55 Exclusion Criteria: History of cancer. History of cardiovascular diseases. Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.
Facility Information:
Facility Name
University of Rome Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Rizza, MD
Email
rizza@med.uniroma2.it
First Name & Middle Initial & Last Name & Degree
Stefano Rizza, MD
First Name & Middle Initial & Last Name & Degree
Manfredi Tesauro, MD
First Name & Middle Initial & Last Name & Degree
Davide Lauro, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19064532
Citation
Muniyappa R, Hall G, Kolodziej TL, Karne RJ, Crandon SK, Quon MJ. Cocoa consumption for 2 wk enhances insulin-mediated vasodilatation without improving blood pressure or insulin resistance in essential hypertension. Am J Clin Nutr. 2008 Dec;88(6):1685-96. doi: 10.3945/ajcn.2008.26457.
Results Reference
background
PubMed Identifier
17724029
Citation
Collins QF, Liu HY, Pi J, Liu Z, Quon MJ, Cao W. Epigallocatechin-3-gallate (EGCG), a green tea polyphenol, suppresses hepatic gluconeogenesis through 5'-AMP-activated protein kinase. J Biol Chem. 2007 Oct 12;282(41):30143-9. doi: 10.1074/jbc.M702390200. Epub 2007 Aug 27.
Results Reference
background
PubMed Identifier
21346065
Citation
Rizza S, Muniyappa R, Iantorno M, Kim JA, Chen H, Pullikotil P, Senese N, Tesauro M, Lauro D, Cardillo C, Quon MJ. Citrus polyphenol hesperidin stimulates production of nitric oxide in endothelial cells while improving endothelial function and reducing inflammatory markers in patients with metabolic syndrome. J Clin Endocrinol Metab. 2011 May;96(5):E782-92. doi: 10.1210/jc.2010-2879. Epub 2011 Feb 23.
Results Reference
derived

Learn more about this trial

Vascular Effects of Hesperidin in Metabolic Syndrome

We'll reach out to this number within 24 hrs